Dolutegravir

What is it?

Dolutegravir (Tivicay®) is used to treat HIV infection, often in combination with other medicines. It is taken in tablet form and works by preventing the HIV virus from replicating in the body.

Is it safe to take dolutegravir in pregnancy?

Dolutegravir is a relatively new medicine and so only small numbers of pregnant women taking it have been studied. A study in 2018 produced some early results which suggest that use of dolutegravir around the time of conception (around 2 weeks before the first missed period) may increase the chance of the baby having a neural tube defect (such as spina bifida). This result is based on only a small number of women taking dolutegravir and in order to confirm it, information from more pregnant women who have taken dolutegravir needs to be analysed. In the meantime, it is recommended that pregnant women and those planning a pregnancy do not use dolutegravir.

Any woman who is taking dolutegravir and is planning a pregnancy should speak to her doctor to discuss the possibility of switching to a different medicine before she conceives. However, there may be some women with HIV for whom other medicines are unlikely to work and use of dolutegravir in pregnancy may therefore be considered less risky than switching to a different medicine. Additionally, the developing baby’s neural tube is closed by the week after the first missed period (5 weeks of pregnancy) and so use of dolutegravir after this stage would not be expected to cause a neural tube defect. Your doctor will be able to help you to weigh up how necessary dolutegravir is to your health against the possible risks to you or your baby, which will depend on how many weeks pregnant you are.
  
This leaflet summarises the scientific studies relating to the effects of dolutegravir on a baby in the womb.

What if I have already taken dolutegravir during pregnancy?

If you have taken dolutegravir in early pregnancy (especially up to the week after the first missed period) it is important to let your doctor or midwife know straight away. A switch in medication may be advised and you may be offered an additional or more detailed ultrasound scan to check for neural tube defects in the baby.

It is important that your doctor reviews all medicines that you are taking if you become pregnant to assess whether you still need them and, if so, to make sure that you are taking the lowest dose that works.

Can taking dolutegravir cause miscarriage?

No large studies have assessed the chance of miscarriage in women taking dolutegravir in early pregnancy.

Can taking dolutegravir in pregnancy cause my baby to be born with birth defects?

A baby’s body and most internal organs are formed during the first 12 weeks of pregnancy. It is mainly during this time that some medicines are known to cause birth defects.

An ongoing study that currently includes 426 women who took dolutegravir around the time of conception (2 weeks before the first missed period) identified that use at this time may be linked to neural tube defects (such as spina bifida) in the baby. However, this finding needs confirmation with further research. Pregnancy outcomes for a total of 188 women using dolutegravir in early pregnancy have been reported in other studies and case reports, and none of their babies were born with neural tube defects. The small amount of available information does not currently suggest a link between use of dolutegravir in early pregnancy and other types of birth defect, but many more women need to be studied to confirm this.

Can taking dolutegravir in pregnancy cause preterm birth or my baby to be small at birth (low birth weight)?

The single study described above includes around 1,700 women taking dolutegravir at any stage of pregnancy and has provided no evidence that this is linked to preterm birth or low infant birth weight. These findings ideally require confirmation with further research.

Can taking dolutegravir in pregnancy cause learning or behavioural problems in the child?

A baby’s brain continues to develop right up until the end of pregnancy. It is therefore possible that taking certain medicines at any stage of pregnancy could have a lasting effect on a child’s learning or behaviour.

No studies have investigated learning and behaviour in children exposed to dolutegravir in the womb.

Will I or my baby need extra monitoring during pregnancy?

Most women will be offered a scan at around 20 weeks of pregnancy to look for birth defects as part of their routine antenatal care. If you have taken dolutegravir in early pregnancy you may be offered additional and/or more detailed ultrasound scans to check for neural tube defects in the baby.

Women with HIV are likely to be more closely monitored during pregnancy, regardless of what medication they are using, to ensure that they remain well, that their baby is growing and developing as expected, and that their medication dose can be adjusted to reduce the risk of the baby contracting HIV in the womb.

Are there any risks to my baby if the father has taken dolutegravir?

We would not expect any increased risk to your baby if the father took dolutegravir before or around the time your baby was conceived.

Who can I talk to if I have questions?

If you have any questions regarding the information in this leaflet please discuss them with your healthcare provider. They can access more detailed medical and scientific information from www.uktis.org